ICH GMPs
This article was originally published in The Tan Sheet
Executive Summary
Availability of "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients" announced by FDA in Sept. 25 Federal Register notice. Guidance, prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, describes cGMPs for manufacturing of APIs. FDA, industry groups will hold four workshops to discuss guidance's impact: Chicago (Oct. 22-24), Princeton, N.J. (Nov. 7-9), Newport Beach, Calif. (Feb. 25-27) and San Juan, Puerto Rico (April 8-10)